Trial Outcomes & Findings for A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old (NCT NCT04414397)

Last Updated: 2024-04-25

Results Overview

The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

205 participants

Primary outcome timeframe

Baseline, Month 3 (Control Period)

Results posted on

2024-04-25

Participant Flow

Of 205 participants screened, 171 were randomized, with 113 in the treatment group and 58 in the control group. One participant was randomized to the treatment group but not treated.

Participant milestones

Participant milestones
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Control Period STARTED	58	113
Control Period COMPLETED	56	106
Control Period NOT COMPLETED	2	7
Post-Control Period STARTED	53	106
Post-Control Period COMPLETED	46	91
Post-Control Period NOT COMPLETED	7	15
Maintenance Treatment Period STARTED	0	40
Maintenance Treatment Period COMPLETED	0	35
Maintenance Treatment Period NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Control Period Withdrawal by Subject	2	2
Control Period Lost to Follow-up	0	4
Control Period Protocol deviation	0	1
Post-Control Period Withdrawal by Subject	3	6
Post-Control Period Lost to Follow-up	4	9
Maintenance Treatment Period Withdrawal by Subject	0	2
Maintenance Treatment Period Lost to Follow-up	0	3

Baseline Characteristics

A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC n=58 Participants Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC n=113 Participants Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.	Total n=171 Participants Total of all reporting groups
Age, Continuous	54.4 years STANDARD_DEVIATION 9.81 • n=5 Participants	54.9 years STANDARD_DEVIATION 9.97 • n=7 Participants	54.7 years STANDARD_DEVIATION 9.89 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	96 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	27 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	86 Participants n=7 Participants	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	94 Participants n=7 Participants	142 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 3 (Control Period)

Population: Modified Intent to Treat Population(mITT): all participants who were randomized and had non-missing Baseline Allergan Temple Hollowing Scale (ATHS) scores. Participants were summarized according to the randomized study intervention. Multiple imputation was used for missing data.

Outcome measures

Outcome measures
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC n=58 Participants Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC n=113 Participants Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC (Post-Control Period) Participants received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Maintenance Period) Participants received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3	13.5 percentage of participants Interval 4.5 to 22.5	80.4 percentage of participants Interval 72.7 to 88.1	—	—

PRIMARY outcome

Timeframe: From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment

Population: Safety population: all participants who were randomized and received study intervention (JUVÉDERM® VOLUMA® XC or no-treatment control), analyzed by treatment received

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.

Outcome measures

Outcome measures
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC n=59 Participants Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC n=112 Participants Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC (Post-Control Period) n=53 Participants Participants received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Maintenance Period) n=40 Participants Participants received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Number of Participants With Adverse Events Any TEAE	3 Participants	38 Participants	24 Participants	13 Participants
Number of Participants With Adverse Events TESAE	2 Participants	5 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Month 3 (Control Period)

The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.

Outcome measures

Outcome measures
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC n=56 Participants Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC n=105 Participants Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC (Post-Control Period) Participants received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Maintenance Period) Participants received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3	10.7 percentage of participants Interval 4.0 to 21.9	83.8 percentage of participants Interval 75.3 to 90.3	—	—

SECONDARY outcome

Timeframe: Month 3 (Control Period)

Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.

Outcome measures

Outcome measures
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC n=51 Participants Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC n=99 Participants Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC (Post-Control Period) Participants received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Maintenance Period) Participants received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3	2.0 percentage of participants Interval 0.0 to 10.4	92.9 percentage of participants Interval 86.0 to 97.1	—	—

SECONDARY outcome

Timeframe: Baseline, Month 3 (Control Period)

The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC n=51 Participants Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC n=100 Participants Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC (Post-Control Period) Participants received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Maintenance Period) Participants received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3	-6.6 units on a scale Standard Deviation 8.90	24.2 units on a scale Standard Deviation 22.32	—	—

SECONDARY outcome

Timeframe: Baseline, Month 3 (Control Period)

The participants responded to each item on the FACE-Q Satisfaction with Temples questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	No Treatment Then JUVÉDERM® VOLUMA® XC n=51 Participants Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC n=100 Participants Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.	JUVÉDERM® VOLUMA® XC (Post-Control Period) Participants received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Maintenance Period) Participants received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire	-4.2 units on a scale Standard Deviation 14.77	42.7 units on a scale Standard Deviation 26.65	—	—

Adverse Events

No Treatment (Control Period)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period)

Serious events: 5 serious events

Other events: 19 other events

Deaths: 0 deaths

JUVÉDERM® VOLUMA® XC (Post-Control Period)

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

JUVÉDERM® VOLUMA® XC (Maintenance Period)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	No Treatment (Control Period) n=59 participants at risk Participants who received no treatment during the first 3 months of the Control Period.	JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period) n=112 participants at risk Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Post-Control Period) n=53 participants at risk Participants randomized to no treatment during the first 3 months of the Control Period who then received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Maintenance Period) n=40 participants at risk Participants randomized to JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period who then received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Infections and infestations LOCALISED INFECTION	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.89% 1/112 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Infections and infestations LYME DISEASE	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.89% 1/112 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Infections and infestations SINUSITIS	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.89% 1/112 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	5.0% 2/40 • Number of events 2 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Infections and infestations STAPHYLOCOCCAL SKIN INFECTION	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.89% 1/112 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Infections and infestations TOOTH INFECTION	1.7% 1/59 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/112 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Infections and infestations URINARY TRACT INFECTION	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.89% 1/112 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Injury, poisoning and procedural complications RADIUS FRACTURE	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/112 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	2.5% 1/40 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/112 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	2.5% 1/40 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	1.7% 1/59 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/112 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Musculoskeletal and connective tissue disorders SYSTEMIC LUPUS ERYTHEMATOSUS	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/112 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	1.9% 1/53 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/112 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	1.9% 1/53 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Reproductive system and breast disorders ENDOMETRIAL HYPERPLASIA	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.89% 1/112 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/53 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	0.00% 0/40 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received

Other adverse events

Other adverse events
Measure	No Treatment (Control Period) n=59 participants at risk Participants who received no treatment during the first 3 months of the Control Period.	JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period) n=112 participants at risk Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Post-Control Period) n=53 participants at risk Participants randomized to no treatment during the first 3 months of the Control Period who then received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. They were followed up to Month 13.	JUVÉDERM® VOLUMA® XC (Maintenance Period) n=40 participants at risk Participants randomized to JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period who then received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
Infections and infestations COVID-19	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	2.7% 3/112 • Number of events 3 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	1.9% 1/53 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	5.0% 2/40 • Number of events 2 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Musculoskeletal and connective tissue disorders PAIN IN JAW	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	5.4% 6/112 • Number of events 11 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	13.2% 7/53 • Number of events 9 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	2.5% 1/40 • Number of events 2 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Musculoskeletal and connective tissue disorders TRISMUS	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	1.8% 2/112 • Number of events 2 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	3.8% 2/53 • Number of events 3 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	5.0% 2/40 • Number of events 3 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received
Nervous system disorders HEADACHE	0.00% 0/59 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	8.0% 9/112 • Number of events 10 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	17.0% 9/53 • Number of events 10 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received	2.5% 1/40 • Number of events 1 • No Treatment (Control Period): from the time of consent up to Month 3 JUVÉDERM® VOLUMA® XC (Control Period + Post-Control Period): from the time of consent up to Month 13 JUVÉDERM® VOLUMA® XC (Post-Control Period): from the time of treatment up to Month 13 JUVÉDERM® VOLUMA® XC (Maintenance Period): from the time of maintenance treatment up to Month 6 Safety population: all participants who were randomized and received study intervention, analyzed by treatment received

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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Restriction type: OTHER